Scientist - Reference Standards, BR&D

Eli Lilly and Company; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Reference Standard Scientist to ensure the technical integrity of reference standards. This vital role involves managing the supply of reference materials, executing technical strategies, and collaborating with global teams to support product testing. The ideal candidate will possess a strong background in analytical chemistry and project management, showcasing problem-solving skills and a keen attention to detail. Join a dynamic team dedicated to improving lives through innovative healthcare solutions and make a significant impact in a collaborative laboratory environment.

Qualifications

• B.S., M.S. or PhD in Chemistry or related field required.
• Significant experience in pharmaceutical analysis or production is essential.

Responsibilities

• Manage reference standard manufacturing, characterization, and inventory.
• Use analytical testing techniques to solve technical problems.

Skills

Analytical Chemistry

Project Management

Statistical Analysis

Problem-Solving Skills

Communication Skills

Compliance Background

Education

B.S. in Chemistry

M.S. in Chemistry

PhD in Chemistry

Tools

Excel

JMP

Computerized Inventory Management Systems

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities.

Position Summary:

The Corporate Reference Standards Organization (CRSO) is responsible for all corporate reference standards used at Lilly. CRSO establishes corporate technical strategy and performs or coordinates the steps required to supply laboratories with approved reference standard materials and supporting data. Activities include specification and acquisition of source material, source batch candidate disposition, formulation and package development/execution, inventory management, order fulfilment, design of analytical testing protocols, evaluation of characterization data, creation and documentation of technical rationale for all decisions, and certification of profiles for reference standards. The result is a consistent supply of accurately defined standards that are demonstrated to be suitable for use in development and commercial global product testing applications.

The Reference Standard Scientist is responsible for ensuring the technical integrity and overall compliance of Lilly reference standards and critical related materials. This includes establishing and maintaining reference standard batch replacement, manufacturing/packaging activities, inventory management, and evaluation testing. The scientist will work closely within the CRSO team and with global customers to ensure efficient and timely support of reference standard material and information deliverables.

Responsibilities:

Technical

• Use knowledge reference standard science, analytical testing techniques, and general analytical chemistry background to solve technical problems and issues.
• Establish and execute reference standard technical strategy including source material selection, packaging, specifications, statistical design, and certification of property values.
• Discern the impact of new batches prepared by a new route that differs from the previously established reference standard batch.
• Work as a critical team member to handle, organize, and utilize complex data sets from multiple sources to enable data driven conclusions.

Project Management

• Manage the timely delivery of work associated with reference standard manufacturing, characterization, and inventory management.
• Monitor existing batches and determine appropriate plans for resupply activities based on manufacturing or source batch acquisition complexity.
• Participate in processes to meet global regulatory commitments associated with reference standards.
• Leverage external vendors for appropriate technical deliverables.
• Manage assigned internal project load, act in a self-directed manner in anticipation of future assignments.

Basic Requirements:

• B.S., M.S. or PhD in Chemistry or related field and significant pharmaceutical analysis or production experience.

Additional Preferences:

• Strong knowledge of analytical sciences including measurement techniques, specifications, statistical analysis of data.
• Project management skillset.
• Experience with the science of reference standards preferred.
• Understanding of chemical synthesis, purification techniques, formulation, packaging, and inventory management.
• Ability to respond to changing priorities while maintaining accuracy and attention to detail.
• Demonstrated scientific problem-solving skills.
• Influencing and coaching skills.
• Experience with computerized inventory management.
• Strong proficiency in statistical tools (e.g., Excel and JMP).
• Strong communication skills.
• Strong compliance background.

Additional Information:

• Travel: 0 to 15%.
• Potential exposure to chemicals, allergens, and loud noises.
• Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N).

Physical Demands/Travel:

The physical demands of this job are consistent with a lab environment.

Work Environment:

This position’s work environment is in a Laboratory.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.